The Human Subjects Core (HSC) will serve all three subprojects and its mandate is to oversee patient[unreadable] protection. The HSC will assure this protection through development of standard operating procedures (SOPs);[unreadable] obtaining IRB approval and verifying Office of Human Research Protection (CHRP) assurances to conduct this[unreadable] research study; providing expert training that requires certification to ensure that each individual is qualified to[unreadable] execute protocol procedures; and ongoing monitoring of compliance with regard to all procedures. HSC will[unreadable] support each subproject is as follows:[unreadable] Subproject #1 (Clinical efficacy). Training and certifying of clinical personnel at each site; Training of study[unreadable] personnel for screening, enrolment, randomization and data collection; training monitoring for data safety.[unreadable] Subproject #2 (Mechanisms of action). Training of study personnel for sample collection, processing and[unreadable] shipping; Monitoring for data safety, sample coding and de-identification.[unreadable] Subproject #3 (Costs and cost-effectiveness). Training of study personnel for data collection (resource[unreadable] units, care logs etc.); Monitoring for data safety (cost and resource use data).[unreadable] All subprojects. Human research protection training; IRB approvals and OHRP assurances; Development of[unreadable] SOPs and Manual of operations and procedures; Auditing and monitoring of sites; Site education.